Kornimate/medical-research-clean huggingface dataset:
soy, catfish, anchovy, and rice supplementation increases 25(oh)d serum levels in tuberculosis patients with complications

Conditions: Tuberculosis

Summary: tuberculosis patients that have complications (e.g., diabetes mellitus and human immunodeficiency virus (hiv)/acquired immunodeficiency syndrome (aids)) who live in tropical regions experience vitamin d deficiency, especially in north sumatra, indonesia. the presence of vitamin d receptor (vdr) polymorphism genes, taqi and foki, is one of the predisposing factors, as is high levels of inflammatory markers, also indicating disease progression and malnutrition. this study aims to assess the effect of 50 g of soy-catfish-anchovy-rice (scar) porridge per day for 14 days on 25(oh)d, calcium, and biomolecular serum levels in patients with vdr gene polymorphisms (taqi or foki). the study was a parallel, open, clinical trial. a total of 43 subjects with the vdr gene polymorphisms were selected. the subjects were divided into two groups using block randomization. there were 22 subjects in the intervention group (i) who received 50 g of scar porridge once per day, along with dietary counseling, and 21 subjects in the control group (c) who only received dietary counseling.

tuberculosis patients that have complications (e.g., diabetes mellitus and human immunodeficiency virus (hiv)/acquired immunodeficiency syndrome (aids)) who live in tropical regions experience vitamin d deficiency, especially in north sumatra, indonesia. the presence of vitamin d receptor (vdr) polymorphism genes, taqi and foki, is one of the predisposing factors, as is high levels of inflammatory markers, also indicating disease progression and malnutrition. this study aims to assess the effect of 50 g of soy-catfish-anchovy-rice (scar) porridge per day for 14 days on 25(oh)d, calcium, and biomolecular serum levels in patients with vdr gene polymorphisms (taqi or foki). the study was a parallel, open, clinical trial. a total of 43 subjects with the vdr gene polymorphisms were selected. the subjects were divided into two groups using block randomization. there were 22 subjects in the intervention group (i) who received 50 g of scar porridge once per day, along with dietary counseling, and 21 subjects in the control group (c) who only received dietary counseling. all subjects in both groups completed the study.

Eligibility criteria:
inclusion criteria: * participants which have newly diagnosed with lung tuberculosis with an acid fast bacilli (afb) result (+), aged 18-60 years, with a heterozygote genotype test performed on one of the genes taqi and foki, willing to participate in the study, and provided informed consent exclusion criteria: * participants which being pregnant and/or a breastfeeding mother

Keywords: polymorphism porridge vitamin d biomolecular
tumor immune microenvironment involvement in colorectal cancer chemoresistance mechanisms

Conditions: Primary Tumor; Colon Tumor

Summary: colorectal cancer is the third most common cancer worldwide and its progression-free survival is still low, around 10 months. thirthy to 50% of patients do not respond to chemotherapy upon initiation of treatment, suggesting that early development of chemoresistance mechanisms remains a major challenge. in order to better characterize these mechanisms, the aim is to develop a model of tumoroids derived from patients with a colorectal tumors prior to any systemic anti cancer treatment. this project will both allow us to study the role of the immunological microenvironment in chemoresistance and identify new predictive markers of tumor response. it will then serve to develop innovative personalized medicine strategies by targeting the newly identified mechanisms. this study should in fine help to improve the cancer patient's care.


Eligibility criteria:
inclusion criteria: * male and female over 18 years old. * managed at the chuga for a colorectal adenocarcinoma * with an indication for immediate surgical resection as part of the care. * patient naive from neo-adjuvant chemotherapy * patient did not object to the crc-orga-2 study exclusion criteria: * patients protected by law (pregnant or breastfeeding women, minors, patients under guardianship or trusteeship, persons deprived of their liberty or hospitalized under duress). * patients with positive hiv, hbv, hcv serology.

Keywords: organoid collection from fresh human primary colonic tumor tissue
non - invasive evaluation of the left atrium anatomy and function

Conditions: Atrial Fibrillation

Summary: the aim of the study is to evaluate the accuracy and reproducibility of the left atrium (la) anatomy and function in different populations and in patients with atrial fibrillation who have undergone cryoballoon ablation.

this study implies three parts. the first part of the study aims to evaluate the variability and reproducibility of rest two - and three-dimensional echocardiography for the left atrium anatomy and function and to assess their correlation with clinical variables. the second part of the study aims to evaluate the accuracy and reproducibility of the left atrium anatomy and function using echocardiography and to validate it with cardiac ct. moreover, the study aims to evaluate which parameters can predict the recurrence of atrial fibrillation in patients who have undergone atrial fibrillation ablation. the third part of the study aims to assess the accuracy and variability of echocardiographic measurements compared to cardiac magnetic resonance and to find predictors of recurrence after cryoballoon ablation for atrial fibrillation.

Eligibility criteria:
inclusion criteria: * subsequent group of patients sent to the echocardiography laboratory for any indication/patients who have undergone a cryoballoon ablation * older than 18 years old exclusion criteria: • inadequate image quality during echocardiography, contraindications for computed tomography or cardiac magnetic resonance
collaborative opioid taper after trauma: preventing opioid misuse and opioid use disorder

Conditions: Opioid Use; Pain, Postoperative; Opioid Use, Unspecified; Trauma; Opioid-use Disorder

Summary: the investigators will enroll 100 participants using a randomized control trial design to implement and evaluate an individualized opioid taper program supporting rural primary care physicians (pcps) caring for patients with moderate to severe trauma discharged on opioids. this study will link a trauma center physician assistant (pa) with rural pcps to facilitate pain care and the individualized opioid taper. the investigators seek to improve patient's pain and opioid outcomes and support the pcps who assume care for these complex patients after hospital discharge. our long term goal is to provide a service that will help trauma patients as they go back into primary care and into pain- and opioid-free living.

this study explores the feasibility, efficacy, and potential sustainability of a collaborative pain care/opioid taper strategy for patients discharged to a rural pcp practice on opioids after hospitalization for moderate to severe traumatic injury. the randomized control study design will provide important pilot data on the efficacy of opioid taper in the context of engaged pain management care at the pcp level when the pcp is supported by expert consultation and has broad implications for patient and clinician education.

Eligibility criteria:
inclusion criteria: 1. must be at least 18 years old 2. injury severity score of 9 or greater 3. resident of washington state 4. will be discharged to a rural zip code outside of king county. 5. glasgow coma score of 15 6. able to read, speak, and write english or spanish. 7. has an identifiable pcp or willing to accept referral to a local federally qualified health center (fqhc) 8. has an insurer included in the all payer claims database 9. planned to be discharged on opioid medication 10. planned to be discharged back to the community exclusion criteria: 1. less than 18 years old 2. injury severity score less than 9 3. patient is in judicial custody 4. resident of a state other than washington 5. will not be discharged to a rural zip code outside of king county. 6. evidence of oud diagnosis (including using heroin or other illicit opioids in the past month, a dsm-5 oud diagnosis, or evidence of taking methadone, buprenorphine, or naltrexone). 7. currently in cancer treatment or enrolled in palliative or hospice care 8. residing in a nursing home or assisted living facility 9. using any implanted device for pain control 10. self-report of heroin or other illicit opioid use in the past month 11. psychotic symptoms, psychiatric hospitalization or suicide attempts in the past year (including current admission).
a 4-year extension study to core 1-year study of iron chelation therapy with deferasirox in β-thalassemia major pediatric patients with transfusional iron overload.

Conditions: Transfusional Iron Overload; β-thalassemia Major; Pediatric Rare Anemia

Summary: in this 4-year extension study the safety, efficacy and and pharmacokinetics of deferasirox in regularly transfused pediatric patients with β-thalassemia major was assessed. patients who successfully completed the main 1 year trial (nct00390858) were eligible to continue in this extension trial and receive chelation therapy with deferasirox for up to 4 years.


Eligibility criteria:
inclusion criteria: * completion of the planned 12-month core trial, (nct00390858). * female patients who have reached menarche and who were sexually active were to use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation. * written informed consent obtained from the patient, and/or from the parent or legal guardian in accordance with the national legislation. exclusion criteria: * pregnant or breast feeding patients * patients with a history of non-compliance to medical regimens and patients who are considered by the investigator as potentially unreliable. other protocol-defined exclusion criteria may apply.

Keywords: β-thalassemia major iron overload deferasirox pediatric rare anemia
vaginal delivery debrief checklist to improve team communication

Conditions: Other Specified Complications of Labor and Delivery

Summary: this study is to determine if using a standardized debrief checklist after vaginal delivery improves communication between the vaginal delivery health care team members and if using the checklist increases a sense of enhanced communication between team members.

this is a study for providers who are a part of the health care team involved with vaginal delivery of newborns. a checklist has been developed that may improve communication between team members following birth. the goal of this study is to evaluate whether the checklist improves or enhances team member communication.

Eligibility criteria:
inclusion criteria: * registered nurses (rns) and licensed practical nurses (lpns) in the women's and children's services department who attend vaginal deliveries as well as providers who attend vaginal deliveries at providence st peter hospital family birth center in olympia washington (wa). exclusion criteria: * none

Keywords: vaginal delivery debrief medical team communication obstetrical safety
enhanced ultrasound in determining extent of disease in women with primary breast cancer

Conditions: Breast Cancer

Summary: rationale: new imaging procedures, such as enhanced ultrasound may improve the ability to determine the extent of breast cancer. purpose: diagnostic study of enhanced ultrasound in women who have locally advanced primary breast cancer.

objectives: i. measure blood flow of primary breast lesions and corresponding lymph nodes by power doppler ultrasound (pdu) and compare this information with metastatic potential and patient survival in women with primary breast cancer. ii. correlate intratumor/-nodal blood flow with pathological variables using standard histology and special stains in this patient population. iii. correlate intratumor microvessel density with total tumor blood flow and with the presence of axillary lymph node metastases using this diagnostic method in these patients. iv. correlate tumor blood flow with various markers of angiogenesis using this diagnostic method in these patients. v. compare tumor blood flow as measured with pdu before and after contrast enhancement in these patients. outline: this is a diagnostic study. patients receive ultrasound contrast agent iv. an ultrasound probe with power doppler facility is swept over the skin surface in a standard fashion before and after contrast enhancement. blood flow data is acquired over the volume of the mass and/or lymph nodes using a video recorder. the scanning time ranges between 5 to 15 minutes depending on the size and exact location of the breast mass and axillary lymph nodes. within 1 week of the ultrasound, patients undergo surgery and the mass and axillary lymph nodes are removed. projected accrual: approximately 200 patients will be accrued for this study within 1 year.

Eligibility criteria:
disease characteristics: clinically suspected locally advanced breast cancer where treatment indicated is primary surgery (wide local excision or simple mastectomy) and axillary dissection (clearance) inflammatory breast cancer eligible no recurrent disease hormone receptor status: not specified patient characteristics: age: 18 and over sex: female menopausal status: not specified performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified cardiovascular: no new york heart association class iii or iv heart disease at least 14 days since prior myocardial infarction pulmonary: no severe chronic obstructive pulmonary disease other: no galactosemia no mental illness or handicap prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior neoadjuvant chemotherapy endocrine therapy: not specified radiotherapy: not specified surgery: see disease characteristics at least 1 month since prior core biopsy (tru-cut) of breast cancer

Keywords: stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer inflammatory breast cancer
assessment of spinal stability

Conditions: Spine Stability; Low Back Pain

Summary: the purpose of this study is to verify the existence of neuromuscular neutral zones(nnzs) in humans, and develop non-invasive techniques to measure intervertebral kinematics of the lumbar spine. the results will be used to accurately quantify nnzs in humans, and provide a foundation for clinical trials on low back pain patients using this methodology.


Eligibility criteria:
inclusion criteria: * 21-45 years of age - typical working age in physically demanding jobs * no history of low back injury or musculoskeletal disorder in the past one year * any activity history: sedentary, active, or non-athletic, and 4) any ethnic background or race * body mass index score less than 30 exclusion criteria: * younger than 21 or older than 45 years old (range not relevant to majority of physical labor force) * previous injury, disorder, or illness related to the low back * professional athletes * professional workers engaged in physical labor (e.g., roofers, loaders/unloaders in warehouses, tile/concrete layers, etc.) * pregnancy

Keywords: lumbar spine low back pain
intraperitoneal paclitaxel plus systemic mfolfox6

Conditions: Gastric Cancer Stage IV; Peritoneal Carcinomatosis; Intraperitoneal Paclitaxel; mFOLFOX6

Summary: treatment for stage 4 gastric cancer with peritoneal carcinomatosis has been unchanged for decades. the median survival for stage 4 gastric cancer is 9-14 months with systemic chemotherapy. intraperitoneal chemotherapy in combination with systemic chemotherapy is under many clinical trials mainly in japan, and are showing promising results. this is korea's first clinical trial on intraperitoneal paclitaxel with systemic mfolfox6 chemotherapy.


Eligibility criteria:
inclusion criteria: * biopsy proven adenocarcinoma of gastric origin, primary or recurrent * identification of peritoneal seeding by ct or diagnostic laparoscopy * patients confirmed to receive mfolfox6 on multidisciplinary outpatient clinic * no previous history of chemotherapy or 4week after the last chemotherapy for gastric cancer * labs adequate for chemotherapy (within 2 weeks of enrollment) * absolute neutrophil count: ≧ 1,500/mm³ * hemoglobin level: ≧ 8.0g/dl * platelet count: ≧ 10×104/mm³ * ast (got), alt (gpt): ≦ 100u/l * total bilirubin: ≦ 2.0mg/dl * creatinine clearance (ccl): ≧ 50ml/min * ecog 0 - 2 * her-2 negative on endoscopic biopsy * age ≧ 20, \< 80 * signed informed consent form exclusion criteria: * patients with other major medical disease or malignant tumors other than gastric cancer * contraindication to 5-fu, oxaliplatin, leukovorin or paclitaxel * pregnant, breast-feeding women or with birth plan * patients refusing treatment

Keywords: gastric cancer peritoneal carcinomatosis intraperitoneal chemotherapy paclitaxel folfox
comparative effectiveness and safety of tiotropium and olodaterol in comparison to laba/ics

Conditions: COPD

Summary: the primary objective is to compare the effectiveness of maintenance therapy initiation with the combination treatment tiotropium and olodaterol (olo+tio) compared with laba/ics combination in copd as the time to the first copd exacerbation. secondary objectives are to compare patients treated with tio+olo and patients treated with laba/ ics combination.


Eligibility criteria:
inclusion criteria: 1. at least one prescription for tio+olo combined inhaler or a laba/ics combined inhaler between 1 january 2013 and 31 march 2019. 1. the first dispensing of either tio+olo or laba/ics combined inhaler will be defined as the index date. 2. for the main analyses, only fixed dose combination (fdc) inhalers will be included. sensitivity analyses will also accept free combinations of laba/ics. 2. at least one diagnosis of copd at any time prior to the index date. 3. at least one year of continuous medical and pharmacy health plan eligibility prior to the index date will be required to allow a baseline period for the covariates and identification of new use of the study drugs. exclusion criteria: 1. to increase the likelihood of a true diagnosis of copd, we will exclude: 1. all patients less than 40 years of age on the index date, and 2. all patients with a diagnosis of asthma in the year prior to the index date 2. to limit the population to those without severe lung compromise outside of copd, we will exclude individuals with lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date 3. to restrict the cohort to new users of tio+olo or laba/ics, we will exclude any individual with use of either tio+olo, laba/ics, or laba/lama/ics combination therapy in free or fixed form for at least one year prior to the index date.
heartmath migraine study

Conditions: Migraine

Summary: this is a two arm study comparing smartphone based heart rate variability biofeedback using the heartmath app and innerbalance sensor to waitlist control on migraine quality of life.

the primary objective of this study is to determine whether there is any superiority between an 8-week program of app based hrv biofeedback (heartmath) compared to wait list control in migraine quality of life. investigators will also look: * to determine whether there is any superiority between an 8-week program of app based hrv biofeedback (heartmath) and wait list control in depression in people with migraine. * to determine whether there is any superiority between an 8-week program of app based hrv biofeedback (heartmath) and wait list control in anxiety in people with migraine. * to determine whether there is any superiority between an 8-week program of app based hrv biofeedback (heartmath) and wait list control in insomnia in people with migraine.

Eligibility criteria:
inclusion criteria: * international classification of headache disorders (ichd) 3 criteria for migraine * 4-20 headache days/month * has not done behavioral therapy for migraine in the past year * has a smartphone and willing to try hrv biofeedback using an app and ear monitor * english speaking * hs graduate or higher level of education * patients must not make preventive medication changes for the course of the study. if patients just changed their preventive medication, they must wait a month before enrolling. exclusion criteria: * doing any form of behavioral therapy for pain in the past year

Keywords: heartmath app inner balance sensor
evaluating a cft group for adults with acquired brain injury

Conditions: Acquired Brain Injury Including Stroke

Summary: emotional difficulties such as anxiety and depression are common after experiencing a brain injury. the compassion focused therapy (or cft) model proposes the importance of developing skills in being able to self-soothe and be self-compassionate to counteract feelings of distress. several studies have shown that therapy groups using cft techniques are helpful, but there has only been one previous study of a cft group with people with acquired brain injury. this study aims to evaluate a new cft group for people who have had a brain injury and are currently receiving inpatient neuro-rehabilitation. the group will have six weekly sessions with 4-6 people in each group. the group will be run at the inpatient neuro-rehabilitation unit. as this is a new group that has not been run before, it will be a small study to see whether the group is feasible and acceptable to attendees. the study will evaluate whether the group can be run as planned and how many people attend. the investigators will also interview people who attended the group to find out what they thought of the group. the study also aims to use four questionnaires measuring emotional distress, well-being, self-compassion and quality of life to measure the effect of the group. group attendees questionnaire scores from before and after the group will be compared to see if there has been any change due to attending the group. this project is being completed as part of a doctorate in clinical psychology at king's college london, and will be recruiting patients from an inpatient neurorehabilitation setting.


Eligibility criteria:
inclusion criteria: 1. has experienced a non-progressive acquired brain injury 2. is at least 18 years old 3. has capacity to consent to take part in the group and associated research project 4. is currently experiencing emotional distress, as identified descriptively by the treating team and indicated by a minimum score of 8 or above (mild symptoms) on the hads. exclusion criteria: 1. has a \[severe\] cognitive impairment to a degree that this is considered by the treating team to prevent their ability to participate in the group despite adaptations. 2. has a \[severe\] communication impairment to a degree that is considered by the treating team to prevent their ability to participate in or understand the group content despite adaptations. 3. is currently experiencing a severe mental health disorder or crisis that would impact on their ability to participate in the group.